Clinical Trials Logo
  1. Home
  2. Anosmia
  3. NCT04657809
  4. Details
NCT04657809 Clinical Trial

Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia

Anosmia Clinical Trial

Official title:
"Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation."

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04657809
Other study ID # S85insu23fdf
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2020
Est. completion date March 20, 2021

Study information
Verified date October 2021
Source Deraya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations 1. Threshold test 2. identification test.

Description:

This study was designed to improve smell disorders after corona infection that is very anxious for all patients. Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up. The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement. The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 20, 2021
Est. primary completion date February 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - anosmia post covid-19 infection Exclusion Criteria: - nasal polyps or fractions or syrgery in nose from 6 months or less

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Insulin film
Insulin suspension vials
Device:
• Fast dissolving film
Fast dissolving film

Locations
Country Name City State
Egypt Soad Minya

Sponsors (2)
Lead Sponsor Collaborator
Soad Ali Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Smell sensation improvement By decrease the threshold sensation with butanol test 4 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04964414 - Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19 Phase 1/Phase 2
Completed NCT05445921 - Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction Phase 1/Phase 2
Completed NCT05812209 - Stellate Ganglion Block to Treat Long COVID 19 Case Series
Withdrawn NCT02179554 - Does Cardiopulmonary Bypass Change Olfaction?
Completed NCT04957563 - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia N/A
Terminated NCT03680911 - NAC for Head Trauma-induced Anosmia Phase 3
Completed NCT04853836 - Olfactory Disfunction and Co-ultraPEALut Phase 4
Recruiting NCT05040659 - Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
Recruiting NCT05562050 - Characteristics of the Anosmic Olfactory Mucosa
Completed NCT05152030 - The Clinical Applicability of the 'TIB' Olfactory Test Device
Recruiting NCT05384561 - Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19 N/A
Enrolling by invitation NCT04764981 - Olfactory Training for Olfactory Dysfunction After Coronavirus Disease - 19 (COVID-19) N/A
Withdrawn NCT04408391 - Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia
Completed NCT04361474 - Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity Phase 3
Completed NCT03990766 - Smell Changes & Efficacy of Nasal Theophylline Phase 2
Completed NCT04797936 - BNO 1030 Extract (Imupret) in the Treatment of Mild Forms of COVID-19 Phase 4
Recruiting NCT04528329 - Anosmia and / or Ageusia and Early Corticosteroid Use Phase 4
Completed NCT04789499 - Smell in Covid-19 and Efficacy of Nasal Theophylline Phase 2
Recruiting NCT04384042 - Malaysian COVID-19 Anosmia Study (Phase 2) - A Nationwide Multicentre Case-Control Study
Completed NCT04390165 - Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional Study